A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
Study ROR-PH-301 is a multicenter, randomized, double-blind, placebo-controlled study. Subjects who meet entry criteria will be randomly allocated 1:1 to receive ralinepag or placebo, in addition to their standard of care or PAH-specific background therapy, as applicable. The primary endpoint is the time (in days) from randomization to the first adjudicated protocol-defined clinical worsening event. All primary endpoint events will be adjudicated by an independent Clinical Event Committee (CEC) in a blinded fashion. Subjects who have a confirmed primary endpoint event adjudicated by the CEC at any time during the study and all subjects on treatment at the conclusion of the study who have completed the Week 28 Visit (after the target number of confirmed events is achieved) will have the option to enroll in an open-label extension (OLE) study. Subjects who do not choose to participate in the OLE study will discontinue study drug and should remain in the study for long-term follow-up of survival status and will receive standard of care PAH treatment, at the discretion of the treating physician.
Inclusion Criteria:
Exclusion Criteria:
Torrance, California 90502, United States
Buenos Aires, Buenos Aires C1039AAO, Argentina
Ciudad Autonoma Buenos Aires, Buenos Aires C1181ACH, Argentina
Caba, Buenos Aires F.D. 1425, Argentina
Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires 1280, Argentina
Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires 1426, Argentina
Ciudad Autonoma Buenos Aires, Ciudad Autonoma Buenos Aires C1093AAS, Argentina
Macquarie, New South Wales 2109, Australia
Belo Horizonte, Minas Gerais 30441-070, Brazil
Porto Alegre, Rio Grande do Sul 90035-074, Brazil
Botucatu, São Paulo 18618-687, Brazil
Sofia, Sofia 1750, Bulgaria
Prague, 128 08, Czechia
Strasbourg, Bas Rhin 67091, France
Grenoble, Isere 38048, France
Vandœuvre-lès-Nancy, Meurthe et Moselle 54511, France
Saint-Étienne-de-Montluc, Pays de la Loire Region 42005, France
Bron, Rhone 69677, France
Heidelberg, Baden-Wurttemberg 69126, Germany
Mainz, Rhineland-Palatinate 55131, Germany
Homburg, Saarland 66424, Germany
Athens, Kallithea 17674, Greece
Thessaloniki, 54636, Greece
Szeged, Csongrád-Csanád Hungary, Hungary
Petah Tikva, 4941492, Israel
Foggia, Foggia 71100, Italy
Palermo, PA 90127, Italy
Roma, Roma 00161, Italy
Milan, 20122, Italy
Mexico City, Mexico City 14080, Mexico
Bialystok, 15-276, Poland
Krakow, 31-202, Poland
Poznan, 61-848, Poland
Lisbon, 1769-001, Portugal
Bucharest, 022328, Romania
Bucharest, 050159, Romania
Cluj-Napoca, 400001, Romania
Timișoara, 300310, Romania
Belgrade, 11080, Serbia
Barcelona, 08035, Spain
Taipei, Taipei 10002, Taiwan
Izmir, 35340, Turkey (Türkiye)
Dnipro, 49070, Ukraine
Kyiv, 03680, Ukraine
Lviv, 79010, Ukraine
Newcastle upon Tyne, Tyne and Wear NE7 7DN, United Kingdom